Columbia Care has announced the initiation of a research study designed to optimize the use of Columbia Care’s precisely-manufactured, pharmaceutical-quality medical cannabis products through the identification of genetic factors affecting their safety and efficacy. Rosemary Mazanet, M.D, Ph.D., Chief Scientific Officer of Columbia Care, and Carlos D. Bustamante, Ph.D., Professor of Biomedical Data Science at Stanford University, President of CDB Consulting Ltd. and Columbia Care Scientific Advisory Board Member will lead the visionary study, which will enroll patients in New York State who are currently taking Columbia Care’s proprietary, precisely-formulated, full-spectrum medical cannabis products.
Dr. Bustamante commented, “Despite the rapid adoption of medical cannabis throughout the country, there is limited evidence on how to determine which combinations of cannabinoids are best suited for an individual’s medical condition and how to appropriately dose medical cannabis products. This lack of knowledge is a major roadblock to enabling precision medicine in this population of patients and currently limits broad adoption of effective treatment by providers and coverage by payers. Furthermore, it creates uncertainty and confusion among patients and policymakers, two of the most important constituencies we want to address. This study will advance genomics and data science by helping Columbia Care and the scientific community understand how genomic factors impact cannabinoid metabolism, collect real-world evidence (RWE) on patients and their outcomes on Columbia Care formulated products, and ultimately guide physicians and patients in choosing the best treatments. This research will better inform both the identification and minimization of adverse events that may be associated with medical cannabis products and optimize the use and benefit of Columbia Care products in patients and consumers.”
Dr. Mazanet continued, “We believe this will provide insights that not only improve our ability to develop better, more efficacious new products, but facilitate payer adoption of our proprietary, precise formulations, which we expect to introduce throughout the US in 2019. Since inception, we have observed that patients with the same qualifying conditions but who take different product doses experience equivalent relief from a variety of unmet medical needs. This study is designed to help us better understand how a patient’s genetic makeup can be used to create a personalized guide for consumers as they move through their experiential journey. The more we see mass adoption of our products into daily routines across the country, the greater the opportunity to provide better outcomes, establish trust and offer completely unique services and insights to build a differentiated reputation in the marketplace. The proprietary data and insights from this study give us unique scale and operational leverage that will enable us to get our patients to their optimal formulation and dosing as quickly as possible, further enhancing the differentiated benefits of products and customer experience that Columbia Care already offers its patients – improving their overall satisfaction and trust in a way that is unique, durable, clinically beneficial and cost-effective.”
The observational, population-based study is expected to enroll hundreds of patients already taking Columbia Care’s patent-pending formulated medical cannabis products in New York State and will examine genetic differences between ultra-rapid, intermediate and poor metabolizers of various formulations of medical cannabis products such as Eleceed™, Theraceed™ and Claraceed™. Through our relationship with DNA Genotek, participants will provide saliva samples using the Oragene·DISCOVER collection kit and participate in follow up data gathering activities to assess impact of therapy, which will be used as a measure of product efficacy. DNA Genotek’s GenoFIND Services will assist in the genotyping analysis of each sample by specifically focusing on a variety of metabolic markers to establish relationships between consumers, cannabinoids and outcomes.
Scott Rabuka, Director, Genomics Program at DNA Genotek, added, “DNA Genotek’s kits enable the easy non-invasive collection of high-quality DNA saliva samples for population-based research. We are delighted that Columbia Care has selected Oragene·DISCOVER collection kits and our GenoFIND services to conduct this innovative study that will enable them to identify genetic factors that affect the efficacy and safety of Columbia Care’s medical cannabis products. We are proud to provide the foundation for this research that has the potential to personalize and clarify the relationship between their cannabis products, outcomes and genetic makeup.”